A tracheostomy is a surgical operation to create an opening (stoma) into the windpipe (the trachea).

A tracheostomy may be needed on an emergency basis to permit a person to breathe who has severe narrowing or blockage (obstruction) of their upper airway.

Tracheostomy may be part of the surgery required for patients who have to have the larynx (voice box) removed because of cancer.

Tracheostomy may also be used for patients who require long-term support with a breathing machine (ventilator).

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.  For the items addressed in this policy, the criteria for "reasonable and necessary," based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

A tracheostomy care kit is covered for a patient following an open surgical tracheostomy which has been open or is expected to remain open for at least three months. 

Claims for tape (A4450 or A4452) that are billed without an AU modifier will be denied as non-covered.  A provider can bill the member for the non-covered item.

A tracheostomy care or cleaning starter kit (A4625) is covered following an open surgical tracheostomy.  Beginning two weeks post-operatively, code A4625 is no longer medically necessary and, if that code is billed, it will be denied as not medically necessary.

One tracheostomy care kit (A4625, A4629) per day is considered necessary for routine care of a tracheostomy.  Claims for additional kits for non-routine tracheostomy care must have substantiating documentation available upon request.

Also, quantities of supplies greater than those described in the policy as the usual maximum amounts, in the absence of documentation clearly explaining the medical necessity of the excess quantities, will be denied as not medically necessary. 

A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

It is expected that the patient's medical records will reflect the need for the care provided.  The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.  This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, there must be clear documentation in the patient’s medical records corroborating the medical necessity of the amount(s).
 
The diagnosis code that justifies the need for these items must be included on the claim.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

A tracheostomy care or cleaning starter kit (A4625) contains the following:

• 1 plastic tray
• 1 basin
• 1 pair of sterile gloves
• 1 tube brush
• 3 pipe cleaners
• 1 pre-cut tracheostomy dressing
• 1 roll of gauze
• 4 4x4 sponges
• 2 cotton tip applicators
• 30 inches twill tape

A tracheostomy care kit for an established tracheostomy (A4629) contains the following:

• 1 tube brush
• 2 pipe cleaners
• 2 cotton tip applicators
• 30" twill tape
• 2 4x4 sponges

A Column II code is included in the allowance for the corresponding Column I code when provided at the same time.

Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

Tracheostomy care kits provided in the first two postoperative weeks should be coded as A4625.

Tracheostomy care kits provided after the first two postoperative weeks should be coded as A4629.

When codes A4450 and A4452 are used with Tracheostomy Care Supplies, they must be billed with the AU modifier.  For this policy, codes A4450 and A4452 are the only two codes for which the AU modifier may be used.

Suppliers should contact the pricing, data analysis and coding (PDAC) contractor for guidance on the correct coding of these items.

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